Diet product comprising alginate

ABSTRACT

The present invention relates to a diet product comprising an alginate in an aqueous dissolved or swelled form at a pH value causing the alginate not to gel until after it is consumed and comes into contact gastric acid.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/524,235 filed Aug. 25, 2009, which is the National Stage ofInternational Application No. PCT/DK2008/050039 filed Feb. 13, 2008,claiming priority based on Danish Patent Application No. PA 2007-00235filed Feb. 13, 2007 and U.S. Provisional Application No. 60/939,796filed May 23, 2007, the contents of all of which are incorporated hereinby reference in their entirety.

INTRODUCTION

The present invention relates to a composition for regulating themetabolism in humans or animals. Particularly, the invention relates toa diet product which can be used to induce loss of weight in persons inneed thereof, a method for regulating food consumption, a method forregulating the diet product consumption as well as methods forregulating the levels of blood sugar or cholesterol in humans oranimals.

BACKGROUND ART

Many good dietary advices exists but experience shows that it is not aneasy matter to get people consuming more soluble dietary fibres eventhough it has long been realized, that this is beneficial to health,especially if one suffers from diabetes or obesity.

For regulating food consumption different dietary fibres are commonlyused. Dietary fibres are grouped into 2 types: soluble and insolublefibres. The insoluble dietary fibres are present in coarse bread andstarchy vegetables. Examples of insoluble fibres comprise cellulose,hemicellulose, lignin and pectin. The soluble fibres are present infruit and vegetables. Examples of soluble fibres comprise guar, dextran,alginate, starch, amylose, amylopectin, xanthan, pullulan, carrageenanand gellan.

US 2004/0228903 discloses a liquid edible composition having a pH ofmore than 5 and containing pectin or alginate together with a calciumsalt. The calcium salt may be present in an amount exceeding its maximumsolubility in the edible liquid, however it will dissolve in the stomachunder the influence of the pH reduction and/or the rise in temperature.Typical calcium salts are CaC03 and CaHP04. The increasing calciumconcentration will stimulate the pectin and/or alginate gellation ascalcium ions and the polysaccharides form a rigid matrix. The alginateor pectin used has a viscosity below 50 cP at a shear rate of 100s″1.

WO 2005/020717 and WO 2005/020719 relate to a food product which inaddition to alginate and insoluble calcium salt also comprises protein.The food product may be a liquid or a spoonable edible product. Thealginate preferably has a molecular weight of at least 0.5×10⁵ and aguluronic acid content of at least 65%.

The rigid matrix is formed when calcium ions is complexed withhomogeneous blocks of guluronic acid in alginate or pectin to form an“egg box” structure. Control of the calcium concentration through outthe gelling process is crucial for a uniform gel to evolve. If theinitial concentration of calcium is too high the polysaccharide willprecipitate rather than forming a gel. The conditions may be difficultto control in the stomach due to interpersonal differences and pre- orpost-eaten food products.

Calcium-induced gelation implies that a high amount of calcium salt mustbe present in the product before consumption. In the drink according toUS 2004/0228903, WO 2005/020717 and WO 2005/020719, the calcium salt ispresent as an insoluble salt. Since the drink prior to ingestiongenerally is desired to have a low viscosity to obtain consumeracceptance the insoluble calcium salt will precipitate during storage.Apart from the inconvenience of shaking the drink before consumption aninhomogeneous product further has the disadvantage that the consumer maynot obtain the calcium salt in a proper dose for an optimal gelation toprogress.

U.S. Pat. No. 5,324,526 discloses an alginate-containing food productaimed at reducing the activity of insulin to synthesize fats fromglucose. The alginate is used as a dietary fibre and is produced bydegradation of commercially available alginate by a certain pressure andtemperature scheme. Alginates with the desired ability to reduce glucosein blood and at the same time stabilise the amount of insulin have anaverage molecular weight of 50.000. If the alginate is shorter, i.e.around a molecular weight of 10.000 the alginate show no tendency toreduce the blood glucose. For an alginate of a molecular weight of100.000 the tendency to reduce blood glucose is similarly reducedcompared to the alginate having a molecular weight of 50.000. Probablydue to the production method, the viscosity of the alginates is low.Thus, a typical alginate of an average weight of 60.000 has at 30° C. inan aqueous concentration of 5.2-5.3% a viscosity of 13 cP.

The low viscosity results in a poor gel strength of the food productwhen the food product is ingested and contacted with the acid in thestomach. If the gel strength is insufficient the physiologicalstimulation of a feeling of satiety will not be so pronounced.

It is the object of the present invention to provide a diet productwhich avoids some or all of the disadvantages of the prior art. Notably,it is desired to provide a diet product which before ingestion has aviscosity low enough for consumer acceptance while at the same time whencontacted with the gastric juice being able to produce a gel strengthsufficient for a consumer to feel satiety.

DESCRIPTION OF THE INVENTION

The invention relates in one aspect to a diet product comprising analginate in an aqueous dissolved or swelled form at a pH value causingthe alginate not to gel.

Alginate is soluble in water and is activated by acid causing the dietproduct of low viscosity to become a thick gel in the stomach due to thelow pH value present here. The activation of alginate by acid is ofimportance as it causes the fibres to have effect in the stomach andfills the stomach like a balloon. Furthermore, it is likely that the gelformed has an active function in detaining fats, thereby inhibitingtheir uptake in the stomach or bowels. By these means some foodconstituents, incl. fats, can pass undigested.

Passage through the stomach and bowels is regulated by the dietaryproduct of the invention as a prolonged time of passage of consumedfoods is observed after intake of the dietary product.

Alginate is, according to the invention, primarily used as an alkalineor alkaline earth metal, eg. sodium, lithium, potassium, calcium etc.Sodium alginate is commonly preferred due to ease of solubility andinclusion hereof on the approved list (E401). Hence, sodium alginate isapproved as an additive to foods. It is widely used in foods where athickening of the food in question is desired. Usually, this involves anactivated sodium alginate in contrast to this invention, wherein adissolved or swelled, but inactivated, sodium alginate is used, whichreacts upon a lowering of the pH value as happens in the stomach. Sodiumalginate can be obtained in pharmaceutical and food approved varieties.Sodium alginate originates in seaweed, especially brown seaweed from theNorwegian Sea. A particular preferred alginate has a viscosity below 800cP in a 4% aqueous solution measured at 20° C. on a Brookfield RVTviscometer, spindle no. 2 at 20 rpm. However, to obtain a sufficient gelstrength when the pH is lowered to about 2-3, the viscosity in a 4%aqueous solution measured at 20° C. on a Brookfield RVT viscometer,spindle no. 2 at 20 rpm, should be above 100 cp. Especially, alginatewith a viscosity below 600 cP, in particular a viscosity between 400 and600, is preferred. A preferred sodium alginate is sold under the name ofSaltialgine™ US 20 by DEGUSSA.

Alginates are polyuronides made up of a sequence of two hexuronic acids:β-D-mannuronic acid and α-L-guluronic acid. Usually, the two sugars arenot distributed at random along the chain, but sometimes form blocks ofup to twenty units. The proportion of these blocks depends on thespecies of seeweed and whether the stripe of the balde of the seaweed isused. Less important factors are the degree of maturity, age and wherethe material was harvested. The ratio of mannuronic to guluronic acid(M/G) in an alginate can vary from 0.4 to 1.6. When the gelling isinduced by calcium ions the gelling properties increase with highercontent of guluronic acid. The present invention is, however, notparticular dependent on the M/G ratio since the gelling of the alginatein the absence of calcium is caused by hydration of the polymer. In acertain aspect an M/G ratio above 1.0 is useful.

The diet product of the invention may contain a minor amount of aninsoluble calcium salt to support the gelation when contacted with thegastric juice. The amount of insoluble calcium salt in the diet productusually provides less than 200 ppm calcium ions when the pH is changedto about pH=2. In a preferred aspect the amount of insoluble calciumsalt in the diet product provides less than 50 ppm dissolved calciumions when the pH is changed to about pH=2. In a preferred aspect,however, the diet product of the invention does not contain an addedinsoluble calcium salt. Insignificant amounts of calcium salts may bepresent in the tap water used for preparation of the diet product. Theinsoluble calcium salts may be salts formed by the combination of thecalcium cation with the carbonate anion or the phosphate anion. Specificexamples of insoluble calcium salts include CaHPO₄ and CaCO₃.

To obtain a sufficiently low viscosity of the diet product the molecularweight of the alginate is usually not above 150,000, more preferred notabove 120,000. However, to obtain a sufficient gel strength whencontacted with the gastric juice the molecular weight of the alginate isusually not below 30,000, more preferably at least 60,000.

Sodium alginate can be formulated in any aqueous solution, includingpure water, almost without any addition of its own taste. In liquidssuch as soft drinks, squash or juice the sodium alginate can be maskedto an extent where it essentially cannot be tasted or felt.

The diet product according to this invention can have any pH value notcausing activation of the sodium alginate. The pH value, at which sodiumalginate gels, is dependent upon origin and pre-treatment. The pH valueis, in an aspect of the related invention, above 4, suitably 5 or above.

The concentration of sodium alginate in the diet product of the presentinvention is adjusted to meet the result desired. In a ready-to-usepreparation the alginate is usually present in a concentration rangingfrom 0.2 to 20 g per kg, mainly 1.5 to 10 g per kg. In anotherembodiment the alginate is present in a concentration intended foraddition to food, including beverages, before consumption.

In an aspect of the invention, insoluble calcium salts are usually notpresent in the diet product in substantial amounts. In aspects of theinvention in which insoluble calcium salts are present, though, theamount thereof is suitably less than 1% weight based on the weight ofthe alginate. Preferably the amount of calcium salts is less than 0.1%weight based on the weight of the alginate.

Besides alginate, the diet product of the present invention canfurthermore contain a mono- or disaccharide, eg. saccharose, glucose orinvert sugar, as a mono- or disaccharide improves the solubility ofalginate. The concentration of mono- or disaccharide is usually chosendepending on the concentration of alginate. According to an aspect ofthe invention the concentration of mono- or disaccharide is in the rangeof 0.1 to 60 g per kg, suitably 10 to 40 g per kg.

The alginates used in the present invention are characterised by acertain increase in the viscosity when the pH is decreased. In a certainaspect of the invention the viscosity of the diet product increased 20times or more when the pH is lowered from around pH 7 to pH 2. Incertain aspect, the increase of the viscosity is 50 times or more, suchas 100 times or more. However, it is generally desired that theviscosity at low pH does not exceeds a certain threshold because itpresently is believed that a too dense gel will cause an unpleasantfeeling by the person ingesting the diet product. Thus, is may bedesired to obtain an increase in viscosity of no more than 100 timeswhen the pH is lowered from around pH 7 to pH 2, such an increase inviscosity of no more than 50 times.

Without being bound by theory, it is presently believed that theviscosity at pH 2 should be at least 500 cP for a sufficient effect tobe obtained. Preferably, the viscosity at pH 2 is 1000 cP or more. Theviscosity is generally kept below 5000 cP because an increased feelingof satiety usually is not obtained above this level. A satisfactoryfeeling of satiety is generally obtained at a viscosity below 2000 cP,such as below 1500 cP.

The diet product of the present invention can be produced in variousembodiments. In one embodiment the diet product is a food, in another astimulant while in a third a pharmaceutical. The diet product can bemeant for cosmetic use, in which it is used in relation to a desire ofloss of weight in order to improve appearance. The diet product can alsobe used on pathologically obese individuals in order to overcome apotentially lethal obesity.

According to an aspect of the invention the diet product is a beverage,eg. a soft drink or a soup. The diet product can be incorporated intoproducts already on the market. This enables the opportunity ofexploiting the distribution system already incorporated at i.e.producers of soft drinks, who have equipment for production anddistribution all over or in parts of the world with the only change toadd alginate to the product. By this means, a soft drink with a slimmingeffect is achieved because the intake of soluble fibres in combinationwith the acid content of the stomach produces a gel.

It is not decisive how the alginate is formulated and distributed. It ispossible to mix the alginate with i.e. sugar in capsules with thepurpose of having the consumer mixing it into a beverage or other foodhim- or herself. Normally, sugar is not desirable in conjunction with adiet product but considering the amount and realizing that even amountsof 1 to 2 g most often will be sufficient prior to a meal, the amount ofsugar is insignificant, even for diabetics. If this is the distributionof choice, it is necessary to have the consumer mixing the ready-to-usecapsules with water, if necessary flavoured, eg. squash or the like, andto carry out thorough stirring before ingestion. It is desirable toingest an appropriate amount of liquid in order to have an optimal useof the fibres and to have an appropriate amount of gel filling thestomach. In order to have an optimal effect, one can, as an example, use0.2 litres of liquid for a capsule containing 0.5-2.0 g of alginate.

It is assumed that the acid activated gel furthermore absorbs anddetains fats thereby causing these to pass through humans undigested.Hereby, a reduced intake of calories is achieved.

It is furthermore assumed that the normal time from ingestion of a mealuntil the fully or partly digested food leaves the body as faeces isprolonged after ingestion of the diet product. This is an especiallydesirable characteristic of these fibres, which is very useful amongindividuals wishing to loose weight, as a reduced ingestion of foodcombined with a prolonged digestion in the body results in lessoscillation of the blood sugar and hence a stabile feeling of satietyand well-being.

Especially diabetics will experience a significant improvement in theregulation of the blood sugar level and at the same time a loss ofweight will enhance an improvement of health in the long term. Thus, thepresent invention also relates to the use of a method for regulating theblood sugar in a patient in need thereof, said method comprising thestep of administering in a pharmaceutically effective amount acomposition containing alginate in a dissolved or swelled form at a pHvalue not causing the alginate to gel.

The present invention also relates to a method of regulating consumptionof food by ingesting the diet product at least 10 minutes prior to amain meal. Typically, ingestion will take place 10 to 30 minutes priorto a meal in order to have an accumulation of mucus in the stomach. Itis well known that individuals often ingest meals too fast as the braintakes approximately 30 minutes to register filling of the stomach andelevation of the blood sugar. By means of this two-part ingestion it isachieved to have the brain aiding in a reduced ingestion of food withouthaving the individual noticing that significantly less calories areingested.

The invention also relates to a method of regulating ingestion of thediet product by ingesting this in an amount causing the faeces to have adensity of 1 g/cm³ or below, mainly 0.9 g/cm³. The density of faeces isfound by registering whether the faeces float in the toilet or not. Useof this diet product in a proper way will lead to floating faeces. Thisis very important as an indicator of proper use. The reduction in faecaldensity is caused because it partly contains swelled or soluble fibresin form of the activated gel. By this means, individuals can themselvesregulate the ingestion of a proper amount of diet product by examiningthe behaviour of their faeces in water.

The daily amount of fibres ingested before a main meal is individual. Anindividual weighing 200 kg ingests significantly more calories than anindividual weighing 90 kg and the stomach of an individual weighing 200kg is likewise significantly larger than in an individual weighing 90kg. Therefore, an individual weighing 200 kg needs to ingest more of thediet product than an individual weighing 90 kg. Everybody can on theirown find the optimal amount by studying their faeces as describedearlier.

EXAMPLES Example 1

A man aged 41 and weighing 113 kg was treated with a diet productcomprising 2.5 g of alginate (Satialgine US 20) dissolved in 0.25 litresof sugar free orange soft drink from Tuborg. The diet product wasingested once a day 15 minutes prior to dinner. After one month oftreatment a loss of weight of 3.5 kg was observed. A prolonged feelingof satiety and well-being was achieved.

Example 2

A man aged 24 and weighing 140 kg was treated with a diet product asdescribed in example 1. The diet product was ingested once a day 15minutes prior to dinner. After one month of treatment a loss of weightof 6.5 kg was observed. A prolonged feeling of satiety and well-beingwas achieved.

Example 3

A woman aged 47 and weighing 56 kg was treated with a diet productcomprising 1 g of alginate (Satialgine US 20) dissolved in 0.25 litresof sugar free orange soft drink from Tuborg. The diet product wasingested once a day 15 minutes prior to dinner. By this means, foodintake was halved yet still achieving the same feeling of satiety asafter a regular main meal. The following day, the dose was raised to 2 gcausing a lack of desire to eat the main meal.

Example 4

A woman aged 49 and weighing 125 kg was treated with a diet productcomprising 2.5 g of alginate (Satialgine US 20) dissolved in 0.4 litresof redcurrant juice without added sugar from COOP. The diet product wasingested 30 minutes prior to dinner causing only half of the normalamount of food to be ingested. Days 2 and 3, the amount of food ingestedwas only 40% of normal. The woman described, that the normal urge forsweets before bedtime was absent.

Example 5

A stock solution was prepared by dissolving 5 g Satialgine US 20 in 1 lof water. While stirring the stock solution the components indicatedbelow for each drink were added.

Orange drink: Stock solution 250 ml Aspartam, 1% aq. 15 g Orangeflavour¹ 0.8 g Beta-caroten, 0.1% in plant oil 0.3 g Carmin colour, 8.2%aq. 0.0001 g Lemon drink Stock solution 250 ml Aspartam, 1% aq. 15 gLemon emulsion 0.4 g Green colour² 0.04 g Passion fruit drink Stocksolution 250 ml Aspartam, 1% aq. 15 g Passion fruit flavour³ 0.2 gBeta-caroten, 0.1% in plant oil 0.3 g Carmin colour, 8.2% aq. 0.0001 gCola drink Stock solution 250 ml Aspartam, 1% aq. 15 g Cola flavour⁴ 0.8g Braun colour⁵ 0.2 g ¹Natural flavour preparation in ethanol. ²Quinolinyellow (E104) 2.0% and Green S (E 142) 0.17%. ³Natural passion fruitflavours in propylene glycol (E 1520) and triacetin (E 422). ⁴Naturalcola flavours in propylene glycol (E 1520) ⁵Ammoniated caramel (E 150d),80% aq.

Example 6 Preparation of a Solution of Alginate and Gelation Thereof

4 g sodium alginate (S20 obtainable from Cargill) was dissolved in 1000ml of deionised water to produce a 0.4% w/w. The viscosity was measuredby a Brookfield LV viscometer, spindle N°2, 20 rpm. At a temperature of22° C. the pH was measured a Philips PW 9420/1 pH meter having theelectrode Metrohm 6.0233.100 to 6.89. The viscosity was measured to35.75 cP.

The pH was then decreased to pH 1.97 using 30 w/w hydrochloric acid. Thegelled alginate was treated with ultra sound to removed entrapped airbubbles. The viscosity was measured to 1150 cP.

Example 7 Preparation of a Solution of Alginate and Gelation Thereof

8 g of a test alginate (XPU—LVG500 506/08 obtainable from Cargill) wasdissolved in 1000 ml deionised water. The pH of the solution was 7.21.The viscosity was measured to 32.5 cp using the method described inexample 6. The solution was acidified using 30 w/w hydrochloric acid topH 2.09. After removal of the majority of the bubbles by ultra sound,the viscosity was measured to 3200 cP.

What is claimed is:
 1. A beverage or drink product comprising analginate in an aqueous dissolved or swelled form, wherein the pH of thebeverage or drink product is pH 5 or more so as to not cause thealginate to gel, wherein the alginate is present at a concentration of0.2 to 20 g per kg of the beverage or drink product, and wherein theviscosity of the alginate increases by 20 to 100 times or more when thepH is decreased upon contact of the product with an acid having a pHcorresponding to gastric acid.
 2. The beverage or drink productaccording to claim 1, wherein the molecular weight of the alginate is150,000 or below.
 3. The beverage or drink product according to claim 1,wherein the alginate has a viscosity in a 4% aqueous solution between100 and 800 cP, measured at 20° C. on a Brookfield RV viscometer,spindle N°2, 20 rpm.
 4. The beverage or drink product according to claim1, wherein the alginate has a viscosity in a 4% aqueous solution between200 and 600 cP, measured at 20° C. on a Brookfield RV viscometer,spindle N°2, 20 rpm.
 5. The beverage or drink product according to claim1, further comprising an insoluble calcium salt, wherein the amount ofinsoluble calcium salt in the beverage or drink product provides lessthan 200 ppm calcium ions when the pH is decreased.
 6. The beverage ordrink product according to claim 5, wherein the amount of insolublecalcium salt in the beverage or drink product provides less than 50 ppmdissolved calcium ions when the pH is decreased.
 7. The beverage ordrink product according to claim 1, wherein the alginate is present at aconcentration of 1.5 to 10 g per kg of the beverage or drink product. 8.The beverage or drink product according to claim 1, further comprisingan insoluble calcium salt, wherein the amount of insoluble calcium saltis present in an amount of less than 1% weight based on the weight ofthe alginate.
 9. The beverage or drink product according to claim 1,wherein the beverage or drink product further contains a mono- ordisaccharide in a concentration of 0.1 to 60 g per kg.
 10. The beverageor drink product according to claim 9, wherein the mono- or disaccharideis selected from the group consisting of saccharose, glucose, invertsugar or mixtures thereof.
 11. The beverage or drink product accordingto claim 1, which is a beverage.
 12. The beverage or drink productaccording to claim 11, which is a soft drink.
 13. The beverage or drinkproduct according to claim 1, wherein the alginate is sodium alginate.14. The beverage or drink product according to claim 13, wherein thealginate is present in a concentrated state.
 15. A method for regulatingconsumption of foods in a subject in need thereof comprising the step ofthe subject consuming an effective amount of the beverage or dinkproduct according to claim 1 at least 10 minutes prior to a main meal.16. A method for regulating consumption of the diet product in a subjectin need thereof comprising the step of the subject consuming thebeverage or drink product according to claim 1 in such amounts that thefaeces has density of 1 g/cm3 or below.
 17. The method according toclaim 16, wherein the faeces has a density of 0.9 g/cm3 or below.
 18. Amethod for regulating the blood sugar in a subject in need thereofcomprising administering to the subject a pharmaceutically effectiveamount of the beverage or drink product according to claim
 1. 19. Amethod for lowering the level of cholesterol in a subject in needthereof, comprising administered to the subject a pharmaceuticallyeffective amount of the beverage or drink product according to claim 1.